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Your Impact:
Senior Commissioning, Qualification and Validation (CQV) Lead
At Jacobs, we'll inspire and empower you to deliver your best work so you can evolve, grow and succeed – today and into tomorrow.With more than 55,000 people in 40+ countries, working at Jacobs offers an exciting range of opportunities to develop your career within a supportive and diverse team who always strive to do the right thing for our people, clients and communities.
People are Jacobs’ greatest asset, and the heart and core of our company. We offer a competitive package to attract and retain the best talent.Work-life balance and flexibility is a key consideration at Jacobs. We’re happy to discuss hybrid, part-time and flexible working hours, patterns and locations to suit you and our business.
In order to support our growth strategy we are seeking applications for the position of Senior CQV Lead. As a Senior CQV Lead with Jacobs you will direct project teams to execute and deliver large scale EPCMV Biotech/Pharma projects located in mainland Europe.
Project is located in the greater Copenhagen area, where the purpose is to build, a state-of-the-art facility. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility will provide Biologics Drug Substance manufacturing for Clinical trials & Commercial Launch.
Responsibilities include:
• Provide Quality management and oversight of the design and qualification activities
• Develop and maintain the project quality activity plan
• Drive the quality activities during the project execution phase from requirement setting, design through construction, verification and system release for process validation
• Supporting the science and risk-based qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
• Support the execution and reporting of the commissioning, qualification and validation activities
• Prepare or review all documentation where required specific to quality activities.
• Ensure any deviations are thoroughly investigated and closed in a timely manner
• Train project members in science and risk-based approach to validation
Here's What You'll Need:
• Significant experience from a similar position within project execution the pharmaceutical or life-sciences industry
• Strong experience with Commissioning, Qualification and Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility
• Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500
• Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15
• Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products
• Track record of utilizing Risk Based Approaches to Qualification / Validation activities
• Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements
#LSeurope
Primary Location
:Denmark-Denmark Countrywide-Albertslund-DK - Copenhagen - Albertslund
Travel
:Yes, 10 % of the Time
Job Posting
:Mar 4, 2024, 4:51:45 AM
Job
:Quality
Organization
:PPS
Job Type
:ExperiencedJob Classification:Fulltime-Regular
Work Locations
:DK - Copenhagen - AlbertslundHersted�stervej 27-29, Building AAlbertslund2620Capabilities:BiopharmaGreat News! We've discovered an exciting live job opportunity for a Senior CQV Lead position in Albertslund Municipality. This job is currently open for hiring/recruiting by Jacobs, exclusively for you at European Jobs. Feel free to download the job details here.
The work culture at Jacobs must adhere to the Ethics of Work Culture as described in the Ethical framework of the UN Charter. You can gain more insights into their local workplace environment by exploring their jobs Jacobs and also by visiting their official website through Google.
The World Cities Report 2020 sheds light on the intrinsic value of sustainable urbanization in Europe, particularly within Albertslund municipality. It explores this value from economic, social, and environmental angles, encompassing the intangible aspects that contribute to Albertslund municipality's distinct character. Moreover, the report delves into the role of innovation and technology, the responsibilities of local governments, targeted investments, and the effective implementation of the New Urban Agenda in promoting sustainable urbanization globally. For a deeper dive into population growth trends and diversity in Albertslund municipality, additional details can be found on Albertslund municipality Wikipedia.
Yes, we found live job(s) for Jacobs in Albertslund Municipality.
Senior CQV Lead jobs are available in Europe.
Exploring the cost of living in Albertslund municipality. At Expertini.Com for Albertslund municipality , we gauge it based on the percentage of earnings to living costs, typically ranging from 33% to 65% of your monthly income. This analysis empowers you to make informed decisions about your financial planning and lifestyle. Additionally, we recommend consulting with locals before making any moves to a new town.
The average salary range for Senior CQV Lead in Albertslund Municipality varies, but the standard pay scale is rated "Standard" in Albertslund Municipality. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively.
To apply for a job at Jacobs follow the application process following the "Apply Now" button at European Jobs and also you can visit Jacobs official career page and follow their application process.
Key qualifications for Senior CQV Lead typically include a list of qualifications and expertise as outlined in Bureau of Labor. Be sure to check the specific job listing for detailed requirements and qualifications.
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Benefits for Senior CQV Lead positions may include a list of benefits. These can vary from company to company, so it's important to review the specific job listing for details on benefits offered by the employer.
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